A Single Center, Single-Blind, Randomized, Crossover Pilot Study to Evaluate the Safety and Effects of Anatabloc™, a Dietary Supplement, in Reducing the Urge to Smoke in Daily Smokers Followed by an Open-Label Extension
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- effect on subject's craving to smoke
研究概览
简要总结
This study will consist of 2 phases. Phase 1 will be a one day crossover study to see the effects of study product on a smoker's desire to smoke, measured by changes in scores on questionnaires given over time. Phase 2 will be a two-week extension, in which subjects will self-administer the study product and visit the study site for assessment of desire to smoke and collection of samples for the evaluation of smoking-related biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 23 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy adult smokers
- •using at least 1 pack of cigarettes per day, for at least 5 years
排除标准
- •allergy to study product components
研究组 & 干预措施
Anatabloc(TM)
dissolvable bit containing dietary ingredients, binders, fillers, and flavors
干预措施: Anatabloc(TM) (Dietary Supplement)
CigRx(R)
dissolvable bit containing dietary ingredients, binders, fillers, and flavors
干预措施: CigRx(R) (Dietary Supplement)
结局指标
主要结局
effect on subject's craving to smoke
时间窗: 5 hours
craving is assessed by changes in questionnaire answers over time
次要结局
- adverse events related to study product(5 hours)